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India's Drug Controller General office announced plans to inspect all of the nation's clinical-trial sites at least annually to verify regulatory compliance. The inspections will cover Schedule Y drugs and cosmetics, good clinical practice and other regulatory requirements. The move follows criticism of the agency's failure to monitor human clinical trials more closely and is part of several other recent measures, including establishing an ethics committee and setting guidelines for compensation to those injured in clinical trials.

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India's Supreme Court has directed state health secretaries to meet with the health ministry to strengthen clinical-trial regulations at a time of deepening concern over a slowdown in approvals for such trials. The Indian Society for Clinical Research said that delays have "the greatest impact on patients for many of whom clinical trial provides early access to a new treatment and for others, the last option or hope of a cure."

The China Food and Drug Administration has established new licensing requirements for the manufacture of high-risk excipients based on toxicity and dosage. The new rules are part of a broader effort to establish a drug master file system similar to the U.S. FDA's. The capacity of China's FDA to register and inspect pharmaceutical and excipient manufacturers is limited and would benefit from third-party audits and stronger self-policing, according to Meredith Ge, former chairwoman of the International Pharmaceutical Excipients Council, who spoke at IPEC-Americas' Excipient Fest in Baltimore.

The European Medicines Agency has announced a timetable for its policy on publicly releasing medical data from clinical trials. The EMA plans to release the draft policy in June, receive public comments through September and publish its final policy at the end of November, with implementation scheduled for January 2014. The final policy will take into account rulings on court cases challenging data transparency mandates, including a recent European Union interim court injunction in favor of drugmakers AbbVie and InterMune. The EMA said its final policy will balance public health interests with the need for patient confidentiality and protection of intellectual property rights.

While 2,868 deaths were reported during clinical trials from 2005 to 2012, the Indian government found only 89 to be directly attributable to the trials. To date, compensation has been paid in only 45 cases. The government has established four committees to monitor the fast-growing growing clinical-trial industry in India, mandating strict requirements for reporting adverse events, including deaths, according to the Ministry of Health and Family Welfare.

A congressional committee grilled Coast Independent Review Board, a Colorado firm for clinical-trial services that evaluates patient safety for drug and device studies, about approving a study submitted by undercover federal investigators that involved a fake surgical product and research team. The hearing is in connection with mounting concern that commercial review boards are too lenient in accepting clinical-trial proposals.